By : Cut Adelia Rizfani 07131015

Principle
The establishment and maintenance of a satisfactory system of quality assurance and correct manufacture of pharmaceutical products relies upon people

General
The manufacturer should have an adequate number of

personnel with the necessary qualifications and practical experience The manufacturer must have an organization chart

Key Personnel
The head of production
The head of quality control The head of quality management

Organization, qualification and responbilities

The head of production should have full authority and responbility including : To ensure that product are produced and stored according to to the appropriate documentation To approve the instructions relating to production operation To check the maintenance of his department

The head of quality control has a responbility including : To approve or reject starting materials, packaging material To ensure that all necessary testing are carried out To approve and monitor any contract analysis To ensure that the appropriate validation are done

The head of quality management has responsibilities including : To ensure implementation To participate in or initiate the development of the companys quality To initiate and participate in external audit

Training
The manufacturer should provide training for all the personnel whose duties take them into productions areas, storage or in control laboratorium

References
National Agency of Drug and Food Control, 2006, Guidelines on Good Manufacturing Practices, Republic of Indonesia.